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HospitalistWeekly 8-20-08
Cardiology
- PCI slightly more effective than meds alone for angina, but only until three years post-op
- Cardiac resynchronization therapy not used appropriately in U.S. hospitals, study suggests
Critical care
- Silver-coated endotracheal tubes may reduce risk for VAP, study finds
Geriatrics
- Take steps to prevent fractures in elderly before discharge, study suggests
Annals of Internal Medicine
- Documentary evidence reveals motives of pharmaceutical “seeding” trials
FDA update
- Class 1 recall for carotid artery stenosis device
- Caution urged when mixing simvastatin, amiodarone
- Tenofovir disoproxil fumarate approved for chronic hepatitis B
From ACP Internist
- On the blog: Genetics may personalize warfarin administration
Cartoon caption contest
- Put words in our mouth: Vote for your favorite entry
Cardiology
.PCI slightly more effective than meds alone for angina, but only until three years post-op
Patients with stable coronary disease who receive percutaneous coronary intervention (PCI) plus medication do slightly better after surgery than those who take medication only, but the advantage disappears after three years, according to a new analysis from the COURAGE trial.
Researchers randomly assigned 2,287 patients with stable coronary disease to PCI plus optimal drug therapy or drug therapy alone. They assessed angina-specific health status using the 19-item Seattle Angina Questionnaire (SAQ), which quantifies physical limitations due to angina, recent change in angina severity, angina frequency, satisfaction with treatment and quality of life. They also used the RAND-36 health survey to assess physical and mental function. The study was published in the Aug. 14 New England Journal of Medicine.
As previously reported, there was no difference between the two groups in terms of death or myocardial infarction after 4.6 years. After three months, 53% of patients in the PCI group were angina-free versus 42% in the drug-only group; the PCI group's SAQ scores were also significantly higher at this time (for example, 85 vs. 80 for decreased angina frequency and 73 vs. 68 for quality of life). In general, PCI patients had small, but significant, incremental benefits for six to 24 months, but these benefits disappeared by 36 months. Patients with more severe and frequent angina saw the greatest benefit from PCI.
Given that drug therapy alone works well and that PCI is expensive and its advantage evaporates over time, it seems reasonable for physicians to try optimal medical therapy first, then turn to PCI if drugs are ineffective for these patients, an editorial writer said. A major challenge for doctors will be to choose optimal medical therapy in a health care system that provides strong financial incentives for PCI, yet few rewards for carefully managing medication, he said.
.Cardiac resynchronization therapy not used appropriately in U.S. hospitals, study suggests
Cardiac resynchronization therapy (CRT) is not used according to current guidelines in U.S. hospitals, a new study reports.
Researchers from the American Heart Association's Get with the Guidelines Steering Committee and Hospitals performed a study to determine how closely use of CRT follows the American College of Cardiology/American Heart Association 2005 guidelines. The guidelines recommend CRT in patients with a left ventricular ejection fraction of 35% or less, a QRS greater than 120 milliseconds and moderate to severe heart failure who do not improve with optimal medical therapy. The study was published online Aug. 12 and appears in the Aug. 26 Circulation.
The authors analyzed data from 33,898 patients at 228 hospitals from January 2005 through September 2007. Overall, only 4.8% of patients with a left ventricular ejection fraction of 35% or less left the hospital with a new CRT implant, and 10% of those who did receive an implant had left ventricular ejection fractions higher than 35%. Patients treated in the northeastern U.S., black patients and older patients were among the groups least likely to receive the therapy (odds ratios, 0.40 [95% CI, 0.30 to 0.53], 0.45 [95% CI, 0.36 to 0.57], and 0.56 [95% CI, 0.48 to 0.65], respectively).
The authors concluded that CRT use in clinical practice varies considerably from its recommended use in current guidelines. Future studies, they wrote, should focus on the reasons for these variations and on development of programs to increase application of evidence-based medicine in patients with heart failure.
Critical care
.Silver-coated endotracheal tubes may reduce risk for VAP, study finds
Endotracheal tubes coated with silver may help reduce rates of ventilator-associated pneumonia (VAP) in critically ill patients, according to a new study.
Researchers from the North American Silver-Coated Endotracheal Tube (NASCENT) Investigation Group performed a randomized, single-blind controlled trial to examine whether patients who received mechanical ventilation using endotracheal tubes coated with silver were less likely to develop VAP. The primary outcome measure was VAP incidence in patients who required ventilation for at least 24 hours. The study, which was funded by the silver-coated tube's manufacturer, appears in the Aug. 20 Journal of the American Medical Association.
Of 1,509 patients who required ventilation for at least 24 hours, 4.8% in the silver-coated group and 7.5% in the uncoated group developed microbiologically confirmed VAP (relative risk reduction, 35.9% [95% CI, 3.6% to 69.0%]). Among all intubated patients (n= 1,932), the corresponding percentages were 3.8% and 5.8% (relative risk reduction, 34.2% [95% CI, 1.2% to 67.9%]). The silver-coated and uncoated groups did not differ in length of intubation or ICU and hospital stay, adverse events, or mortality rates.
The authors acknowledged several important limitations of their study, including the overall low VAP rate, single-blind design and higher rate of chronic obstructive pulmonary disease (COPD) in the uncoated group. Nevertheless, they concluded that the silver-coated endotracheal tube safely decreased microbiologically confirmed VAP in their study population, without requiring extra work on the part of clinicians.
An accompanying editorial praised the trial's "stringent, carefully defined microbiological and clinical criteria for diagnosing VAP" but pointed out that the results were not robust and that, among other factors, the imbalance of preexisting COPD between groups and the lack of information on antibiotics used to treat VAP were of concern. "Silver-coated tubes should not be viewed as the definitive answer for VAP prevention," the editorialist wrote, and should be used only in high-risk patients in ICUs where VAP prevention strategies fall short of institutional goals.
Geriatrics
.Take steps to prevent fractures in elderly before discharge, study suggests
Elderly patients often have a higher risk of fracture following hospitalization, presenting an opportunity for hospitals to take preventive steps before discharge, a recent study found.
In the prospective study, researchers analyzed the medical records of 3,075 white and black men and women age 70 to 79 years who were hospitalized between 1997-1998. After an almost seven-year follow-up period, 66% of the patients were admitted to a hospital and 26% were admitted three or more times. Risk of fracture increased with the number of times a patient had been admitted to the hospital, with those admitted three or more times having a 3.66-fold increased relative hazard for hip fracture (95% CI, 1.78 to 7.53). The findings are published in the Aug. 11/25 Archives of Internal Medicine.
The findings have important clinical implications because they identify a group at high risk for fractures who could benefit from interventions, researchers noted. Because the risk of fracture is greatest soon after discharge, the hospital stay is a good time to evaluate fracture risk, by measurement of bone mineral density, assessment of fall risk, and initiation of treatments to reduce bone loss. The authors recommended that hospitals develop guidelines for assessing and reducing risk of fracture in this population.
Treating vitamin D deficiency to decrease bone loss, increase muscle strength and improve coordination should be incorporated into the care and discharge process for older adults, the researchers noted. Other interventions might include instituting structured walking or exercise programs; screening and treating impaired visual function; and initiating treatment with risedronate or bisphosphonates to protect against bone loss.
Annals of Internal Medicine
.Documentary evidence reveals motives of pharmaceutical “seeding” trials
A new study finds strong evidence that pharmaceutical company trials done as marketing but posed as scientific research are harmful.
Clinical studies designed by pharmaceutical companies to promote use of their drugs are called “seeding” trials. While much has been written about the marketing tactics of the pharmaceutical industry, seeding trials have not been characterized in depth.
Researchers reviewed internal documents that became public during litigation against the drug manufacturer. The company’s marketing division designed the trial, and handled all collection, analysis and dissemination of data. The company hid its motive for the trial from participants, investigators and institutional review board members. Researchers concluded that seeding trials are harmful for three reasons:
- Because the company disguises its motives, informed consent is impossible;
- Good-quality research is at risk when marketers rather than scientists design a study; and
- The scientific question posed by a seeding trial often has little merit.
An accompanying editorial warns institutional review boards to avoid approving seeding trials and physicians to avoid enrolling their patients in them.
The study and its accompanying editorial appear in the Aug. 19 Annals of Internal Medicine.
FDA update
.Class 1 recall for carotid artery stenosis device
The FDA last week issued a Class 1 recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008, due to a product defect.
Used to treat carotid artery stenosis, the product is being recalled because the tip of the stent delivery system may detach during a stenting procedure, which could cause vessel wall injury, stroke and/or emergency surgery to remove the tip. The recall doesn’t affect stents that have already been implanted.
.Caution urged when mixing simvastatin, amiodarone
Physicians should avoid prescribing more than 20 mg of simvastatin (Zocor, Vytorin, Simcor) per day if a patient is taking amiodarone (Cordarone, Pacerone), because the combination increases the risk of rhabdomyolysis, the FDA said in an alert.
The risk of rhabdomyolysis with the combination is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. This risk was described in 2002 in revised simvastatin labeling, but FDA still receives reports of the combination being used, and of adverse results, it said.
.Tenofovir disoproxil fumarate approved for chronic hepatitis B
The FDA last week approved tenofovir disoproxil fumarate (Viread) for chronic hepatitis B in adults.
The recommended daily dose is 300 mg. Patients who discontinue the drug should have their hepatic function monitored closely for several months, as acute exacerbations of hepatitis have occurred in those who stopped treatment, the drug's manufacturer said.
The manufacturer also recommends assessing creatinine clearance (CrCl) before starting treatment with the drug, and monitoring CrCl and serum phosphorus in patients at risk. Tenofovir disoproxil fumarate, which has been available in the U.S. since 2001 to treat HIV infection, shouldn't be administered with concurrent or recent use of nephrotoxic drugs, and all patients should be offered HIV antibody testing before starting the drug, the manufacturer said.
The most common side effects to the drug are nausea, abdominal pain, diarrhea, headache, dizziness, fatigue, nasopharyngitis, back pain and skin rash.
From ACP Internist
.On the blog: Genetics could personalize warfarin administration
Genetic studies could personalize warfarin administration, making this tricky medication easier to use. The NIH has reviewed the evidence on vitamin D—what does it mean for your practice? Find these stories and a new edition of Medical News of the Obvious at ACP Internist's blog.
Cartoon caption contest
.Put words in our mouth: Vote for your favorite entry
Our cartoon caption contest continues. ACP staff has selected three finalists for the latest contest and is now asking readers to vote for their favorite caption to determine the winner.
Go online to view the cartoon and pick the winner, who receives a copy of "Medicine in Quotations," ACP's comprehensive collection of famous sayings relating to sickness and health, disease and treatment and a portrait of medicine throughout recorded history.
Test Yourself
A 52-year-old woman is evaluated for a 6-week history of generalized malaise and fatigue. She received a kidney transplant 15 years ago for hypertension-related renal failure. What type of infection is the most likely cause of this patient’s worsening kidney function?
ACP Career Connection
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